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Hepatitis C - Treatment-Naive |
| IDEAL |
A study of response rates comparing Peg-Intron/Rebetol vs. Pegasys/Copegus
in hepatitis C patients with genotype 1. Eligible patients will receive 12 months of antiviral therapy and
6 months of follow-up. |
| Viramidine |
A Pharmacokinetic study of Viramidine, a ribavirin-analog that has been shown in some studies
to cause less hemolytic anemia than ribavirin, providing the potential for efficacy with less side effects. This study is limited to
Caucasian or African-American patients with hepatitis C - genotype 1. There is a weight restriction, and eligibile patients
may receive Viramidine during a "lead-in" phase before receiving the Peg-Intron/Viramidine combination therapy. |
Latino Trial
|
A study of response rates in Caucasian patients vs. Latino patients with hepatitis C -
genotype 1. Treatment is with Pegasys/Copegus. Eligible patients will receive 12 months of antiviral therapy and 6
months of follow-up. Sorry, the study is now only open to Latino patients who have no cirrhosis on liver biopsy. |
| Polymerase Inhibitor Trial |
A phase I trial with oral drug involving overnight stays and pharmacokinetic studies. This
will be a first use in humans. Will start 1st Quarter of 2006. |
| Protease Inhibitor Trial |
A Phase II study comparing three treatment groups in genotype 1 patients:
PEG-IFN + RBV, PEG-IFN + VX950, and PEG-IFN + RBV + VX950. VX950 is a protease inhibitor which appears to reduce
viral load at a significantly faster rate than standard of care treatment. Treatment length will depend on which group
patients are randomized into (either 12 or 48 weeks). Will start 1st Quarter of 2006. |
| Hepatitis C - Treatment-Nonresponders |
| Anti-HCV Monoclonal Antibodies Trial |
A Phase I study of virological effects of two human anti-HCV monoclonal antibodies in
ascending single dose fashion. This drug will be infused intravenously. |
| Fibrosis Trial |
A Phase II study of anti-fibrotic activity of an oral drug. Study will involve
serial liver biopsies. |
| Thrombocytopenia Trial |
Use of a thrombopoietin receptor agonist in this Phase II study. Requires platelet counts
between 20K and 70K. This drug has a platelet-raising effect within 10 days. Lead-in phase followed by antiviral treatment with
pegylated interferon and ribavirin. |
| Hepatitis B |
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| Compensated Hepatitis B |
A study of Tenofovir vs. Adefovir Dipivoxil in patients who are HBeAg-positive, with less than
12 weeks prior nucleoside or nucleotide treatment, elevated liver enzymes and viral load. Prior HBeAg test results are requested as part
of entry criteria. Eligible patients will receive 48-240 weeks of treatment. |
| Decompensated Hepatitis B |
A study of Tenofovir vs. Emtricitabine plus Tenofovir vs. Entecavir in decompensated patients with
a Child-Pugh score of 7 to 12. Patients must not have used Tenofovir or Entecavir before and have less than 24 months of treatment
with Hepsera. |
| Other
Studies |
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| GERD |
Phase IV study for patients with a history of reflux disease for at least 6 months. There is a double-blined,
placebo-controlled run-in period of 1 week followed by treatment with pantoprazole for 7 weeks. |
| Novartis (Dyspepsia) |
For Female patients
with Dyspepsia, an opportunity to receive oral tegaserod (6mg
bid). |
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